Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology Indications Compared With the US Food and Drug Administration Accelerated Approval Program

被引:0
|
作者
Ho, Cheryl [1 ,2 ]
Lim, Howard J. [1 ,2 ]
Regier, Dean A. [3 ,4 ]
机构
[1] BC Canc, Dept Med Oncol, 600 W 10th Ave, Vancouver, BC V5Z 4E6, Canada
[2] Univ British Columbia, Dept Med, Vancouver, BC, Canada
[3] BC Canc, Canc Control Res, Vancouver, BC, Canada
[4] Univ British Columbia, Sch Populat & Publ Hlth, Vancouver, BC, Canada
关键词
D O I
10.1001/jamanetworkopen.2021.20301
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页数:4
相关论文
共 50 条
  • [41] Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety
    Kuderer, Nicole M.
    Lyman, Gary H.
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (18) : 1773 - +
  • [42] Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications
    Lee, Samuel J.
    Cho, Lauren
    Klang, Eyal
    Wall, James
    Rensi, Stefano
    Glicksberg, Benjamin S.
    [J]. JAMA NETWORK OPEN, 2021, 4 (06) : E2112562
  • [43] Evolution of health technology assessment: best practices of the pan-Canadian Oncology Drug Review
    Rocchi, Angela
    Chabot, Isabelle
    Glennie, Judith
    [J]. CLINICOECONOMICS AND OUTCOMES RESEARCH, 2015, 7 : 287 - 298
  • [44] Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer
    Yamashita, Kenji
    Kaneko, Masayuki
    Narukawa, Mamoru
    [J]. EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY, 2019, 75 (09) : 1193 - 1200
  • [45] The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements
    Wallach, Joshua D.
    Ross, Joseph S.
    Naci, Huseyin
    [J]. CLINICAL TRIALS, 2018, 15 (03) : 219 - 229
  • [46] Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer
    Kenji Yamashita
    Masayuki Kaneko
    Mamoru Narukawa
    [J]. European Journal of Clinical Pharmacology, 2019, 75 : 1193 - 1200
  • [47] Clinical benefit of randomized controlled trials (RCT) supporting US Food and Drug Administration (FDA) conversion from accelerated to full approval
    Borrell Puy, M.
    Molto Valiente, C.
    Ocana Fernandez, A.
    Templeton, A.
    Seruga, B.
    Gich, I.
    Barnadas, A.
    Amir, E.
    Tibau, A.
    [J]. ANNALS OF ONCOLOGY, 2017, 28
  • [48] Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration
    Egilman, Alexander C.
    Kapczynski, Amy
    McCarthy, Margaret E.
    Luxkaranayagam, Anita T.
    Morten, Christopher J.
    Herder, Matthew
    Wallach, Joshua D.
    Ross, Joseph S.
    [J]. JOURNAL OF LAW MEDICINE & ETHICS, 2021, 49 (03): : 456 - 485
  • [49] Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
    Zhang, Audrey D.
    Puthumana, Jeremy
    Downing, Nicholas S.
    Shah, Nilay D.
    Krumholz, Harlan M.
    Ross, Joseph S.
    [J]. JAMA NETWORK OPEN, 2020, 3 (04)
  • [50] US Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks
    Lee, Theodore T.
    Kesselheim, Aaron S.
    [J]. ANNALS OF INTERNAL MEDICINE, 2018, 168 (10) : 730 - +